FDA recall D-0333-2015

Akorn, Inc. · Class III · drug

Product

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).

Reason for recall

Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-12-09
Report date: 2015-01-14
Termination date: 2017-01-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0333-2015